NCT01816503

Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study

High-dose Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 636 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show the clinical usefulness of fentanyl matrix by measuring satisfaction with pain treatment after administering fentanyl matrix in patients whose pain was not controlled sufficiently with the previous analgesic use in real practice at the investigator's discretion.

Detailed description

This is a multi-center, open-label (all people know the identity of the intervention), prospective (the patients are identified and then followed forward in time for the outcome of the study) observational study. The study population comprises patients who are admitted to a study center during the study period and are receiving a strong oral long-acting opioid analgesic but deemed to control pain insufficiently. Since this study is an observational study conducted in real practice, a dose of fentanyl matrix should be adjusted depending on an individual patient's response at the investigator's discretion. However, for the patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics, the minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust dosage according to the degree of the patients' pain control during the 9 days of the study period.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	No intervention	This is an observational study. The minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust the dosage according to the degree of the patients' pain control during the 9 days of the study period. Fentanyl matrix is a transdermal patch that is applied on the patient's skin.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2013-03-22
• Last updated: 2013-03-22